Depressive SymptomsNCT05122429
Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies
A study testing e-Health Treatment in people with Depressive Symptoms and Anxiety, run by Stony Brook University at 1 site in United States.
Trial summary
The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Stress
- What is being tested?
- e-Health Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 17 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+years old;
- Masters of Art degree or higher in social/biomedical(medicine)/physical science, engineering or mathematics
- current elevated distress as measured by the Depression Anxiety and Stress Scale, 21 item version(≥ 5 on DASS Depression Subscale OR ≥ 4 on DASS Anxiety Subscale OR ≥ 8 on DASS Stress Subscale) (DASS, Lovibond \& Lovibond, 1995); and, (5) ≥ 5 on any subscale of the Sheehan Disability Scale (SDS, Sheehan 1983).
Who cannot join
- Any current or recent (i.e. past month) suicide ideation
- any history of suicide attempt (within past 5 years)
- serious mental illness (i.e., psychosis, mania)
- alcohol or substance dependency during the past 6 months
- serious medical problems (e.g., seizures, cancer)
- current participation in psychotherapy
- new use of psychoactive medications (i.e., benzodiazepines for less than 1 month or selective serotonin reuptake inhibitors [SSRIs], tricyclics, or serotonin-norepinephrine reuptake inhibitors [SNRIs] for less than 3 months).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mind-Body Clinical Research Center
Stony Brook, New York, 11790
About this study
The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated). The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support. The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.
Read the detailed description
The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated). Participants will be healthy, high functioning adults (e.g., medical residents, postdoctoral fellows in the sciences, math, and engineering) who report elevated psychological distress, mood or anxiety symptoms. Participants will complete a self-guided online therapy program (MyCompass) and will be randomized to receive one of the following: (1) online therapy without therapist support, 2) online therapy plus therapist support via electronic text-based messaging (i.e., secure email), or 3) online therapy plus therapist support via video messaging. Outcomes will be evaluated weekly via online self-report measures of psychological distress, mood, anxiety, number of hours and quality of sleep, fatigue, and resiliency indicators (i.e., coping and mindfulness). The investigators will examine changes over time in outcomes across all three groups. The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support. The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.
- Conditions
- Depressive Symptoms, Anxiety, Stress, Impairment
- Being tested
- e-Health Treatment
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-Health TreatmentBehavioural
Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.
| Study group | Role | What they receive |
|---|---|---|
| myCompass Only | Experimental | Self-guided e-health treatment Receives: Behavioral: e-Health Treatment |
| myCompass + Delayed Text Therapy Support | Experimental | Self-guided e-health treatment with delayed (44min) text support from a therapist. Receives: Behavioral: e-Health Treatment |
| myCompass + Delayed Video Therapy Support | Experimental | Self-guided e-health treatment with delayed (44min) video support from a therapist. Receives: Behavioral: e-Health Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional impairment in work/school, social life, and family life change
Sheehan Disability Scale is a 3 item measure to assess functional impairment in work/school, social life, and family life.
Measured: Change from baseline at 6-weeks assessments, 1-weeks post treatment, and 1-month post treatment
Symptoms of Depression, Stress, and Anxiety Change
Depression Anxiety and Stress Scale is a 21-item measure to assess the severity of Depression, Stress, and Anxiety.
Measured: Change from baseline at 6-weeks assessments, 1-week post treatment, and 1-month post treatment
Secondary outcomes (3)
Sleep Quality Change
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item questionnaire that assesses seven components of sleep quality (subjective sleep quality, sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction). Each component is rated on a 0-3 severity scale referring to the frequency of each disturbance, and yields a global score with a range of 0-21.
Measured: Change from baseline at 1-week post treatment and 1-month post treatment
Fatigue Severity Change
The Fatigue Severity Scale (FSS) measures fatigue and its effects on functioning. The FSS is comprised of nine items rated on a Likert-type rating scale (1-7), where one indicates no impairment and seven indicates severe impairment.
Measured: Change from baseline at 1-week post treatment and 1-month post treatment
Treatment Satisfaction
The ARMS-12 measures confidence, comfortability, and perceptions towards the program. The ARMS-12 is comprised of 12 items rated on a Likert-type rating scale (1-7), where one indicates the how strongly the agree or disagree with the statement.
Measured: 1-week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start6 Nov 2017
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Gonzalez, Stony Brook University
- Investigators
- Adam Gonzalez, PHD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122429
- Sponsor's protocol ID
- NNX15AN64G
- Status last verified
- Nov 2021
- First submitted
- 18 Oct 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo X, Bugatti M, Molina L, Tilley JL, Mahaffey B, Gonzalez A. Conceptual Invariance, Trajectories, and Outcome Associations of Working Alliance in Unguided and Guided Internet-Based Psychological Interventions: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2022 Jun 21;9(6):e35496. doi: 10.2196/35496.
PubMed 35727626
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies
- ClinicalTrials.gov ID
- NCT05122429
- Acronym / sponsor ID
- NNX15AN64G
- Conditions
- Depressive Symptoms, Anxiety, Stress, Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated). The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support. The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.
Detailed description
The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated). Participants will be healthy, high functioning adults (e.g., medical residents, postdoctoral fellows in the sciences, math, and engineering) who report elevated psychological distress, mood or anxiety symptoms. Participants will complete a self-guided online therapy program (MyCompass) and will be randomized to receive one of the following: (1) online therapy without therapist support, 2) online therapy plus therapist support via electronic text-based messaging (i.e., secure email), or 3) online therapy plus therapist support via video messaging. Outcomes will be evaluated weekly via online self-report measures of psychological distress, mood, anxiety, number of hours and quality of sleep, fatigue, and resiliency indicators (i.e., coping and mindfulness). The investigators will examine changes over time in outcomes across all three groups. The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support. The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| myCompass Only | Experimental | Behavioral: e-Health TreatmentSelf-guided e-health treatment |
| myCompass + Delayed Text Therapy Support | Experimental | Behavioral: e-Health TreatmentSelf-guided e-health treatment with delayed (44min) text support from a therapist. |
| myCompass + Delayed Video Therapy Support | Experimental | Behavioral: e-Health TreatmentSelf-guided e-health treatment with delayed (44min) video support from a therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+years old;
- Masters of Art degree or higher in social/biomedical(medicine)/physical science, engineering or mathematics
- current elevated distress as measured by the Depression Anxiety and Stress Scale, 21 item version(≥ 5 on DASS Depression Subscale OR ≥ 4 on DASS Anxiety Subscale OR ≥ 8 on DASS Stress Subscale) (DASS, Lovibond \& Lovibond, 1995); and, (5) ≥ 5 on any subscale of the Sheehan Disability Scale (SDS, Sheehan 1983).
Key exclusion criteria (7 listed)
- Any current or recent (i.e. past month) suicide ideation
- any history of suicide attempt (within past 5 years)
- serious mental illness (i.e., psychosis, mania)
- alcohol or substance dependency during the past 6 months
- serious medical problems (e.g., seizures, cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-Health TreatmentSelf-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist. | Behavioural | myCompass + Delayed Text Therapy Support, myCompass + Delayed Video Therapy Support, myCompass Only |
Primary outcome
Functional impairment in work/school, social life, and family life change
Time frame: Change from baseline at 6-weeks assessments, 1-weeks post treatment, and 1-month post treatment
Sheehan Disability Scale is a 3 item measure to assess functional impairment in work/school, social life, and family life.
Symptoms of Depression, Stress, and Anxiety Change
Time frame: Change from baseline at 6-weeks assessments, 1-week post treatment, and 1-month post treatment
Depression Anxiety and Stress Scale is a 21-item measure to assess the severity of Depression, Stress, and Anxiety.
3 secondary outcomes
Sleep Quality Change
Time frame: Change from baseline at 1-week post treatment and 1-month post treatment
Fatigue Severity Change
Time frame: Change from baseline at 1-week post treatment and 1-month post treatment
Treatment Satisfaction
Time frame: 1-week post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Derived from this study: PubMed 35727626Luo X, Bugatti M, Molina L, Tilley JL, Mahaffey B, Gonzalez A. Conceptual Invariance, Trajectories, and Outcome Associations of Working Alliance in Unguided and Guided Internet-Based Psychological Interventions: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2022 Jun 21;9(6):e35496. doi: 10.2196/35496.
Related trials for Depressive Symptoms
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Gonzalez, PHD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-Health Treatment in people with Depressive Symptoms and Anxiety, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional impairment in work/school, social life, and family life change (time frame: Change from baseline at 6-weeks assessments, 1-weeks post treatment, and 1-month post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.